Trial Outcomes & Findings for The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder (NCT NCT03310775)

Results Overview

The ADOS is a play-based, semistructured, standardized assessment of communication, social interaction, and play (i.e. imaginative use of materials) for individuals with a suspected diagnosis of autism or ASD. The ADOS consists of four modules, each of which can be selected on the basis of the participant's expressive language skills and hronological age. Module 4 of the ADOS is designed for adolescents and adults with fluent speech, and includes 10 essential and 5 optional activities. The scores from each activity are coded as well as those for five subdomains: language and communication, reciprocal social interaction, imagination, stereotyped behaviors and restricted interests, and other abnormal behaviors. minimum 0, maximum 18, higherscores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

baseline, after the completion of the treatment, 4 month

Results posted on

2020-09-09

Participant Flow

The participants were recruited from the Child and Adolescent Psychiatric Clinic at Seoul National University Bundang Hospital, through advertisements at the Smile Together Foundation (a local advocacy institute of ASD), a community of child and adolescent psychiatrists, an internet group of families of youth with ASD.

Ten participants were excluded during the randomization procedure; six were not adequately motivated, one did not meet the diagnosis of ASD, one had difficulty understanding self-report scales, one had a problem with school, and one had to fulfill a military commitment.

Participant milestones

Participant milestones
Measure	Case Group Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Overall Study STARTED	19	18
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Case Group Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Overall Study Lost to Follow-up	2	3
Overall Study aggravation of depression	0	1

Baseline Characteristics

The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Case Group n=19 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=18 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23.3 years STANDARD_DEVIATION 3.7 • n=5 Participants	23.5 years STANDARD_DEVIATION 4.1 • n=7 Participants	23.4 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Korean	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment South Korea	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, after the completion of the treatment, 4 month

The ADOS is a play-based, semistructured, standardized assessment of communication, social interaction, and play (i.e. imaginative use of materials) for individuals with a suspected diagnosis of autism or ASD. The ADOS consists of four modules, each of which can be selected on the basis of the participant's expressive language skills and hronological age. Module 4 of the ADOS is designed for adolescents and adults with fluent speech, and includes 10 essential and 5 optional activities. The scores from each activity are coded as well as those for five subdomains: language and communication, reciprocal social interaction, imagination, stereotyped behaviors and restricted interests, and other abnormal behaviors. minimum 0, maximum 18, higherscores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month communication	3.3 score on a scale Standard Deviation 1.0	3.6 score on a scale Standard Deviation 1.3
Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month social interaction	7.5 score on a scale Standard Deviation 2.1	8.8 score on a scale Standard Deviation 2.3
Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month Stereotyped behaviors and restricted interests	1.0 score on a scale Standard Deviation 0.2	1.1 score on a scale Standard Deviation 0.2
Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month Imagination	0.4 score on a scale Standard Deviation 0.6	0.6 score on a scale Standard Deviation 0.1

PRIMARY outcome

Timeframe: baseline, 4 month

The TYASSK is a 22-item criterion-referenced test developed for this study to assess the teen's knowledge about the specific social skills taught during the intervention. Two items were derived from key elements of each of the 11 didactic lessons. Teens were presented with sentence stems and asked to choose the best option from two possible answers. Scores range from 0 to 22, with higher scores reflecting greater knowledge of teen social skills.

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Change From Baseline in Test of Young Adult Social Skills Knowledge(TYASSK) at 4 Month	17.5 score on a scale Standard Deviation 4.3	21.7 score on a scale Standard Deviation 3.4

PRIMARY outcome

Timeframe: baseline,4 month

The SSRS consists of 38-items and took approximately 10 min to complete. Questionnaires were completed independently by the teen's parent and teacher. For example, items included ''Starts conversations rather than waiting for someone to talk first.'' The items were rated as either ''Never,'' ''Sometimes,'' or ''Very Often.'' The Social Skills and Problem Behaviors scales were derived from factor analysis. minimum 50 and maximum 163, and higherscores mean a better outcome

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Change From Baseline in Korean Version of the Social Skills Rating System (K-SSRS) at 4 Month	115.7 score on a scale Standard Deviation 32.5	108.4 score on a scale Standard Deviation 26.3

PRIMARY outcome

Timeframe: baseline,4 month

The SRS is a 65-item questionnaire that assesses the various dimensions of interpersonal behavior, communication, and repetitive/stereotypic behavior that are characteristics of ASD. minimum 92, maximum 200, higherscores mean a worse outcome

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Change From Baseline in Social Responsiveness Scale-2 (SRS-2) at 4 Month	146.5 score on a scale Standard Deviation 22.9	147.9 score on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: baseline,4 month

The K-VABS is an interviewed survey and measures adaptive behaviors of individuals such as personal and social skills, used for everyday living from birth to age 90. These are based on the reports of primary caregivers and teachers. The K-VABS contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional). Behaviors are rated on a 0 (a skill that is not used by the individual) - 2 (a skill used most of the time) rating scale. The current study used only the communication, daily living skills, and socialization domains. minimum 25, maximum 108, higherscores mean a better outcome.

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Korean Version of the Vineland Adaptive Behavior Scale, Second Edition communication	75.0 score on a scale Standard Deviation 13.4	70.5 score on a scale Standard Deviation 16.4
Korean Version of the Vineland Adaptive Behavior Scale, Second Edition daily living skills	78.3 score on a scale Standard Deviation 16.5	74.4 score on a scale Standard Deviation 20.9
Korean Version of the Vineland Adaptive Behavior Scale, Second Edition socialization	71.9 score on a scale Standard Deviation 18.3	65.9 score on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: baseline,4 month

The BDI consists of 21 items measuring the severity of subjective symptoms of depression, with emotional, cognitive, motivational, and physiological symptom profiles for adults. Each question has four possible answer choices, scored from 0 (no symptoms) to 3 (the most severe symptoms). minimum 1, maximum 45, higherscores mean a worse outcome

Outcome measures

Outcome measures
Measure	Case Group n=17 Participants Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects. Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.	Waitlist Control Group n=14 Participants For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Change From Baseline in Beck Depression Inventory (BDI) at 4month	12.8 score on a scale Standard Deviation 10.2	14.5 score on a scale Standard Deviation 11.4

Adverse Events

Case Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miae Oh

Kyunghee university hospital, Seoul, South Korea

Phone: 82-10-8929-5048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place